What is the FDA product code for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

DXX. It is classified under 21 CFR 870.1290 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05

Q: Who is the manufacturer of NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

Stereotaxis, Inc. filed the 510(k) submission for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 (K051760).

K051760 · Stereotaxis, Inc. · DXX · May 5, 2006 · Cardiovascular

Device Facts

Record ID	K051760
Device Name	NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
Applicant	Stereotaxis, Inc.
Product Code	DXX · Cardiovascular
Decision Date	May 5, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1290
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

Device Story

Interventional workstation for remote navigation of magnetically-adapted catheters/guidewires. System uses two computer-controlled permanent magnets to generate magnetic fields (up to 0.10 T) to orient device tips. Operated by physicians from a control room or table-side via an enhanced navigation interface. Requires digital fluoroscopy for visualization. Physician provides computer commands to steer device through tissue to target sites in heart/coronary vasculature. Benefits include precise, remote-controlled navigation of interventional devices.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by performance testing and reference to clinical/animal data from predicate K032937.

Technological Characteristics

System utilizes two mechanically positioned permanent magnets to generate magnetic fields up to 0.10 T. Operates as an interventional workstation requiring digital fluoroscopy. Software-controlled interface for physician-directed steering of magnetically-adapted catheters/guidewires. No direct patient tissue contact.

Indications for Use

Indicated for navigation of compatible magnetic devices (catheters/guidewires) through tissue to target sites in the right and left heart and coronary vasculature.

Regulatory Classification

Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

Predicate Devices

Navigant™ Workstation/Niobe® Magnetic Navigation System (K032937)

Related Devices

K060967 — NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION · Stereotaxis, Inc. · Oct 19, 2006
K032937 — NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 · Stereotaxis, Inc. · Jul 1, 2004
K021555 — STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM · Stereotaxis, Inc. · Jan 15, 2003
K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS) · Stereotaxis, Inc. · Nov 6, 2025
K183027 — Steerable catheter control system · Stereotaxis, Inc. · Sep 6, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ K051760 Stereotaxis, Inc. Navigant™/Niobe® Magnetic Navigation System צו # Appendix 1: 510(k) Summary of Safety and Effectiveness | Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule “...510(k) Summaries and 510(k) Statements...” (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device description | The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer- controlled permanent magnets for orienting the tip of a magnetic device. | | | The system employs magnetic fields to orient or steer the tip of a magnetic device. | | | The NWS05 is a modification to the Navigant™ Workstation/Niobe® Magnetic Navigation System (K032937). The changes introduce new software design and mode of operation, new hardware, and a new range of motion to improve imaging, but maintain the existing technology for orientation of magnetically-adapted devices and clinical utility. | | | The NWS05 requires a digital fluoroscopy system to function properly. | | Intended use | The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS. | | Substantial equivalence | The NWS05 is substantially equivalent to the Navigant™ Workstation/Niobe® Magnetic Navigation System (K032937). | | | Continued on next page | | Technological characteristics | The NWS05 employs magnetic fields to orient the distal tip of a magnetically-adapted device (e.g., catheter or guidewire). | : {1}------------------------------------------------ ### Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued Device comparisons steering control The following is a comparison of the key features of The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] vs. the predicate device, the Navigant™ Workstation/Niobe® Magnetic Navigation System (NWS2; K032937). | Device Characteristics | New Device - NWS05 | Predicate Device - NWS2 | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | To navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. | To navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. | | Direct contact with patient tissue | No | No | | Remote physician control of steerable device distal orientation | Yes | Yes | | Computer control of steerable device distal orientation | Yes | Yes | | Conducted under fluoroscopic visualization | Yes | Yes | | Guided magnetic device employed | Specially designed magnetic catheters/guidewires | Specially designed magnetic catheters/guidewires | | Steering control | Via magnetic fields, from a control room or at patient table side | Via magnetic fields, from a control room or at patient table side | Continued on next page {2}------------------------------------------------ 3/3 ## Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued Device comparisons - steering control (continued) | | Device Characteristics | New Device - NWS05 | Predicate Device - NWS2 | |--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------| | | System command | Physician-directed computer command | Physician-directed computer command | | | Magnetic field source | Two permanent magnets – positioned mechanically | Two permanent magnets – positioned mechanically | | | Operating field strength | Up to 0.10 T | Up to 0.10 T | | Physical testing | Performance testing has demonstrated substantial equivalence of the new device to the predicate device. | | | | Preclinical animal and clinical performance data | The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] is a modification of the predicate NWS2. Animal and clinical data are not necessary to support the modifications. Application data (animal and clinical) for magnetic navigation were provided and/or referenced in K032937. | | | | Contact | Peter A. Takes, Ph.D., RAC Director, Clinical & Regulatory Affairs Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, Missouri 63108 Ph. 314-615-6964 Fax 314-615-6912 takesp@stereotaxis.com | | | | Date | March 11, 2005 | | | and and the commended and and a successful a second for a comments a comments of the comments of the forme of . . . {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement around the caduceus symbol. The image is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 5 2006 Stereotaxis. Inc. c/o Mr. Uwe Degenhardt TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K051760 > Trade Name: Navigant™ Workstation with Niobe® Magnetic Navigation System, Version NWS05. Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: 74 DXX Dated: April 19, 2006 Received: April 20, 2006 Dear Mr. Degenhardt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Blummenhofer Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K051760 Device Name: Navigant™ Workstation with Niobe® Magnetic Navigation System Indications For Use: The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use .(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bbitmuma sion of Ca Biolk) Numb Page 1 of 1